A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms

Recruiting now · Phase 1

Conditions studied: Myeloproliferative Neoplasms

In brief

This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.

Key facts

Study ID

NCT06313593

Run by

Incyte Corporation

People needed

186

Starts

2024-08-08

Expected to finish

2028-10-09

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• MF:
• Intermediate-1 or higher risk PMF, post-PV MF, or post-ET MF with evidence of minimum burden of disease based on splenomegaly, and for the monotherapy cohort, participants must have been previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment.
• For the MF SubOpt R cohort: Therapeutic regimen prior to enrollment as defined in the protocol and unlikely to benefit from further monotherapy in the opinion of the investigator.
• PV: Confirmed diagnosis of PV and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.
• ET: Confirmed diagnosis of high-risk ET as defined in the protocol and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.
• Life expectancy > 6 months.
• Willingness to undergo a pretreatment and regular on-study bone marrow biopsies and aspirations (as appropriate to disease).
• Existing documentation of JAK2V617F mutation from a qualified local laboratory.

You may not qualify if…

• Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, post-ET MF, PV, or ET.
• Prior history of major bleeding or thrombosis within the 3 months prior to study enrollment.
• Participants with abnormal hematologic, hepatic, or renal function based on laboratory evaluation.
• Has undergone prior allogenic or autologous stem-cell transplantation or allogenic stem-cell transplantation is planned
• Active invasive malignancy.
• Significant concurrent, uncontrolled medical condition.
• Acute or chronic HBV, active HCV or known HIV.
• Any prior MPN-directed therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
• Participants undergoing treatment with G-CSF or GM-CSF, romiplostim, or eltrombopag at any time within 4 weeks before the first dose of study treatment.
• Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where it is running

• The University of Alabama At Birmingham — Birmingham, Alabama, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center — Fairway, Kansas, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Cornell Medical Center — New York, New York, United States (enrolling)
• Icahn School of Medicine At Mount Sinai — New York, New York, United States (enrolling)
• Sloan Kettering Institute For Cancer Research — New York, New York, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States (enrolling)
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States (enrolling)
• Md Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Princess Margaret Cancer Center — Toronto, Ontario, Canada (enrolling)
• Hopital Maisonneuve-Rosemont, Montreal, Qc — Montreal, Quebec, Canada (enrolling)
• McGill University Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
• Hospital Saint Louis — Paris, France (enrolling)
• Institut Gustave Roussy — Villejuif, France (enrolling)
• University Medical Center Rwth Aachen — Aachen, Germany (enrolling)
• Universitatsklinikum Halle (Saale) — Halle, Germany (enrolling)
• Haukeland University Hospital — Bergen, Norway (enrolling)
• Oslo University Hospital — Oslo, Norway (enrolling)
• Inselspital - Universitaetsspital Bern — Bern, Switzerland (enrolling)
• Universitatsspital Zurich — Zurich, Switzerland (enrolling)
• Guys and St Thomas Nhs Foundation Trust — London, United Kingdom

Full record on ClinicalTrials.gov

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